The Recall Desk
HighFDA (Devices)·Z-1489-2019·Announced 2019-06-05

Change Healthcare Recalls Horizon Cardiology Hemo Software Due to Medication Discrepancies

Change Healthcare Israel Ltd. is recalling 125 units of Horizon Cardiology Hemo software because it fails to notify users of medication discrepancies, potentially affecting patient data and reports.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device software defect that can lead to incorrect medication data in patient records and reports. While no specific injuries or illnesses are reported in the source text, the risk of harm from medication discrepancies in a clinical setting justifies a High severity rating under the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Change Healthcare Israel Ltd. is recalling 125 units of Horizon Cardiology Hemo software, specifically versions 11.x and 12.x. The recall is due to a software defect where users are not notified of procedure medication discrepancies between the Vitals and Meds, Procedure Notes, and Patient Common Data screens.

This discrepancy may also affect administered medication data in reports generated from Hemo or the Horizon/McKesson Cardiology Physician's Report. Additionally, it may impact customers who have implemented an outbound interface of procedure results.

The affected software was distributed nationwide to 43 states and internationally to Australia, Canada, Germany, Ireland, Israel, and the United Kingdom. Healthcare facilities using this software should contact Change Healthcare for further instructions on resolving the data discrepancy issue.

The recalled product

Product
Horizon Cardiology Hemo
Manufacturer
Change Healthcare Israel Ltd.
Category
Medical Device — Software
Hazard
Affected units
125

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software version 11.x and 12.x

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Change Healthcare Israel Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Change Healthcare Israel Ltd.

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Same hazard · data integrity

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